STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)— 510(k) K132006

Substantially Equivalent

Hartalega Sdn Bhd

FDA 510(k) clearance K132006 for STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU), Substantially Equivalent on 2013-11-07. Applicant: Hartalega Sdn Bhd.

Clearance details

Applicant: Hartalega Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2013-07-01
Decision date: 2013-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Selangor, Darul Ehsan, MY

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Adverse events under product code LZA

product code LZA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.